Assessing Fluid-responsiveness Using Non-invasive Hybrid Diffuse Optics on Peripheral Muscle

ConditionCritical Illness

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorCorporacion Parc Tauli

About this trial

Proof-of-concept observational study including ICU patients undergoing a PLR maneuver. Local microvasculature will be assessed with the hDOS platform on the brachioradialis muscle, deriving the microvascular blood flow index (BFI) and tissue oxygen saturation (StO2). CO will be assessed via an invasive hemodynamic monitor based on pulse waveform analysis through the patient's arterial line. The correlation over time between CO and microvascular parameters, and the ability of microvascular variables for predicting a positive CO response (increase \> 10%) will be assessed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Invasive blood pressure monitoring through an arterial line

Disqualifiers

Patients with suspected pregnancy

Intra-abdominal hypertension

Elevated intracranial pressure

Trial population

ICU patients with their blood pressure invasively monitored through an arterial line

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Passive Leg Raising maneuver
Other intervention
The PLR will be performed using automatic bed adjustment: Starting from a semi-recumbent position, the lower limbs will be elevated to a 45° angle while the trunk will be moved from semi-recumbent to supine. After three minutes, subjects will be returned to the initial semi-recumbent position.

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: Critical care patient1 intervention

Trial outcomes

Primary outcomes

Cardiac Output Response

The relative increase in % of the Cardiac Output (CO), from baseline during the Passive Leg Raising (PLR) test (at 60-120 seconds within the maneuver), will be calculated. Those subjects with a relative increase equal to or above 10% will be classified as CO-responders to the PLR. On the other hand, if the increase in CO during the PLR is below 10%, subjects will be classified as non-responders.

Time frame

During procedure

Sponsors and contacts

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Corporacion Parc Tauli

Lead sponsor

Institut de Ciències Fotòniques (ICFO)

Collaborator

Source ClinicalTrials.gov

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